Nos.
92-1168, 92-1179
United States Court of Appeals, District of Columbia Circuit
Alliance for Cannabis Therapeutics v. Drug Enforcement
Administration
15 F.3d 1131 (D.C. Cir. 1994)
Decided Feb 18, 1994
Nos. 92-1168, 92-1179.
Argued October 1, 1993.
1132 Decided February 18, 1994. *1132
Petitions for Review of an Order of the Drug
Enforcement Administration.
Steven K. Davidson, Washington, DC, argued the
cause for petitioners. With him on the briefs were
Amy W. Lustig, Washington, DC, and Kevin B.
Zeese, Alexandria, VA. Thomas C. Collier, Jr.,
Washington, DC, entered an appearance for
petitioner Alliance for Cannabis Therapeutics and
intervenors in No. 92-1168.
Lena D. Mitchell, Attorney, U.S. Dept. of Justice,
Washington, DC, argued the cause for respondent.
With her on the brief was John C. Keeney, Acting
Asst. Atty. Gen. Eumi L. Choi, Washington, DC,
entered an appearance for respondent.
Steven K. Davidson and Amy W. Lustig,
Washington, DC, were also on the brief for
intervenors.
Before MIKVA, Chief Judge, and BUCKLEY and
GINSBURG, Circuit Judges.
Opinion for the court filed by Circuit Judge
BUCKLEY.
BUCKLEY, Circuit Judge:
The Alliance for Cannabis Therapeutics, the Drug
Policy Foundation, and the National Organization
1133 for the Reform of Marijuana *1133 Laws petition
for review of a final order of the Administrator of
the Drug Enforcement Administration declining to
reschedule marijuana from Schedule I to Schedule
II of the Controlled Substances Act. Rescheduling
to Schedule II would permit doctors to prescribe
marijuana for therapeutic purposes. Petitioners'
central claim is that the Administrator's order rests
on an unreasonable interpretation of the statute.
Because our previous disposition of this matter in
Alliance for Cannabis Therapeutics v. DEA, 930
F.2d 936 (D.C. Cir. 1991) (" ACT") constitutes the
law of the case, we decline to reconsider this
claim. We also find that the Administrator
satisfied ACT's mandate on remand and that
petitioners' other claims lack merit.
I. BACKGROUND
A. Statutory Scheme
The Controlled Substances Act ("CSA") places
hazardous drugs in five categories, or schedules,
which impose varying restrictions on access to the
drugs. See 21 U.S.C. § 812 (1988). Marijuana is
assigned by statute to Schedule I, the most
restrictive of these. See id. Schedule I drugs may
be obtained and used lawfully only by doctors
who submit a detailed research protocol for
approval by the Food and Drug Administration
and who agree to abide by strict recordkeeping
and storage rules. See 21 C.F.R. §§ 1301.33,
1301.42.
The CSA allows the Attorney General to
reschedule a drug if he finds that it does not meet
the criteria for the schedule to which it has been
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assigned. 21 U.S.C. § 811(a). The Attorney
General has delegated this authority to the
Administrator. See 28 C.F.R. § 0.100(b). In
rescheduling a drug, the Administrator must
consider, inter alia, "[s]cientific evidence of [the
drug's] pharmacological effect, if known," and "
[t]he state of current scientific knowledge
regarding the drug or other substance." 21 U.S.C.
§ 811(c)(2), (3).
A drug is placed in Schedule I if (1) it "has a high
potential for abuse," (2) it has "no currently
accepted medical use in treatment in the United
States," and (3) "[t]here is a lack of accepted
safety for use of the drug . . . under medical
supervision." 21 U.S.C. § 812(b)(1) (1988)
(emphasis added). The Schedule II criteria are
somewhat different: (1) the drug "has a high
potential for abuse," (2) it "has a currently
accepted medical use in treatment in the United
States or a currently accepted medical use with
severe restrictions," and (3) "[a]buse of the drug . .
. may lead to severe psychological or physical
dependence." 21 U.S.C. § 812(b)(2) (1988)
(emphasis added). Petitioners' central claim is that
the Administrator misinterpreted the language
italicized above.
B. Procedural History
This is the latest chapter in petitioners' efforts to
move marijuana into a less restrictive CSA
schedule. They claim that marijuana is
misclassified because it has been shown to serve
various medicinal purposes. Specifically, they
contend that marijuana alleviates some side effects
of chemotherapy in cancer patients, aids in the
treatment of glaucoma, an eye disease, and
reduces muscle spasticity in patients suffering
from multiple sclerosis and other maladies of the
central nervous system. In support of these
contentions, they introduced affidavits and
testimony of a number of patients and practicing
physicians who insist that, in their experience,
marijuana has proven safe and effective.
15 F.3d 1131 (D.C. Cir. 1994)
The petition to reschedule marijuana was first
filed in 1972 and has been before this court on
four prior occasions — National Org. for the
Reform of Marijuana Laws v. Ingersoll, 497 F.2d
654 (D.C. Cir. 1974); National Org. for the
Reform of Marijuana Laws v. Drug Enforcement
Admin., 559 F.2d 735 (D.C. Cir. 1977); National
Org. for the Reform of Marijuana Laws v. Drug
Enforcement Admin. Dep't of Health Education
Welfare, No. 79-1660 (D.C. Cir. Oct. 16, 1980);
and most recently, ACT, 930 F.2d 936 (D.C. Cir.
1991). ACT is the only part of this history we need
recount.
In ACT, the Alliance for Cannabis Therapeutics
("Alliance") and the National Organization for the
Reform of Marijuana Laws ("NORML") argued
that the Administrator's refusal to reschedule
marijuana rested on an unreasonable interpretation
of the statutory phrase, "currently accepted
1134 medical use." *1134 930 F.2d at 939; see 21 U.S.C.
§§ 812(b)(1)(B), (2)(B). In a scheduling
proceeding involving another drug, the
Administrator determined that "[t]he
characteristics of a drug or other substance with an
accepted medical use" include:
(1) scientifically determined and accepted
knowledge of its chemistry;
(2) the toxicology and pharmacology of
the substance in animals;
(3) establishment of its effectiveness in
humans through scientifically designed
clinical trials;
(4) general availability of the substance
and information regarding the substance
and its use;
(5) recognition of its clinical use in
generally accepted pharmacopeia, medical
references, journals or textbooks;
(6) specific indications for the treatment of
recognized disorders;
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(7) recognition of the use of the substance
by organizations or associations of
physicians; and
(8) recognition and use of the substance by
a substantial segment of the medical
practitioners in the United States.
53 Fed.Reg. 5,156, 5,157-58 (Feb. 22, 1988).
Applying these criteria to the petition to
reschedule marijuana, the Administrator found on
December 29, 1989, that marijuana had no
currently accepted medical use and thus had to
remain in Schedule I. 54 Fed.Reg. 53,767, 53,768
(1989). The eight-factor test had been published in
the Federal Register on February 22, 1988, 17
days after the close of the evidence but before the
oral arguments to the administrative law judge in
the marijuana rescheduling proceedings.
On reviewing the Administrator's decision, we
found the eight-factor test for determining whether
a drug had a "currently accepted medical use" to
be "in the main acceptable." ACT, 930 F.2d at 937.
We noted the ambiguity of the phrase and the
dearth of legislative history on point and deferred
to the Administrator's interpretation as reasonable.
Id. at 939 (citing Chevron U.S.A. Inc. v. Natural
Resources Defense Council, 467 U.S. 837, 843-45,
104 S.Ct. 2778, 2782-83, 81 L.Ed.2d 694 (1984)
(court may not substitute its own construction of
ambiguous statutory provision for reasonable
interpretation by agency of statute entrusted to its
administration)). We were troubled, however, by
1135 view, the law of the *1135 case doctrine applies
three of the eight criteria and remanded the case
"for an explanation as to how [these] had been
utilized by the Administrator in reaching his
decision." Id. at 940. In particular, we were
concerned over the apparent impossibility of
meeting the fourth, fifth, and eighth criteria, all of
which assumed an availability of marijuana for
medical purposes that was prohibited by Schedule
I.
15 F.3d 1131 (D.C. Cir. 1994)
On March 26, 1992, the current Administrator
issued the order that is the subject of this appeal.
See 57 Fed.Reg. 10,499 (Mar. 26, 1992) ("Final
Order"). He concluded, on remand, that his
predecessor had not in fact relied on two of the
three "impossible" criteria; he explained the third;
and, after applying new criteria, he again denied
the petition to reschedule marijuana. Id. at 10,508.
II. DISCUSSION
A. Law of the Case
We held, in ACT, that the Administrator's
interpretation of the CSA was reasonable. Under
the "law of the case" doctrine, appellate courts do
not reconsider matters resolved on a prior appeal
in the same proceeding. 18 Wright Miller, Federal
Practice Procedure § 4478 at 788 (1981). The
doctrine is not a jurisdictional limitation; rather, it
"merely expresses the practice of courts generally
to refuse to reopen what has been decided. . . ."
Messenger v. Anderson, 225 U.S. 436, 444, 32
S.Ct. 739, 740, 56 L.Ed. 1152 (1912). Thus, courts
will reconsider previously decided questions in
such exceptional cases as those in which there has
been an intervening change of controlling law, or
new evidence has surfaced, or the previous
disposition has resulted in clear error or manifest
injustice. 18 Wright Miller, § 4478 at 790.
Petitioners do not contend that any of these
exceptions apply here. Instead, they assert that in
ACT we gave only cursory attention to the
statutory interpretation argument whereas, in their
only where the prior appeal has analyzed an issue
at length. We disagree on both counts. First, our
treatment of the statutory interpretation question
was entirely adequate. Second, even summarily
treated issues become the law of the case. In
Christianson v. Colt Industries Operating Corp.,
486 U.S. 800, 817, 108 S.Ct. 2166, 2178, 100
L.Ed.2d 811 (1988), the Supreme Court noted:
"That the Federal Circuit did not explicate its
rationale is irrelevant, for the law of the case turns
on whether a court previously `decide[d] upon a
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rule of law' — which the Federal Circuit
necessarily did — not on whether, or how well, it
explained the decision." In ACT, we decided that it
was not "an unreasonable application of the
statutory phrase [for the Administrator] to
emphasize the lack of exact scientific knowledge
as to the chemical effects of the drug's elements."
930 F.2d at 939.
As noted above, our only concern, in ACT, was
with three of the standards adopted by the
Administrator and his possible reliance on them.
As a consequence, in remanding the case, we
asked him to explain how his decision had been
affected by those standards. In the Final Order, the
present Administrator found that two of these
criteria — the "general availability of the
substance" and the "use of the substance by a
substantial segment of . . . medical practitioners"
— played no role in his predecessor's decision.
See 57 Fed.Reg. at 10,507.
Further, the Administrator found that his
predecessor's conclusion that marijuana failed to
meet the third of the questioned criteria —
"recognition of [the drug's] clinical use in
generally accepted pharmacopeia" — rested on a
determination that marijuana lacked a known,
reproducible chemistry. See id. We had objected to
the "recognition of clinical use" standard only
because it seemed to require widespread
therapeutic use of the drug — an impossibility for
Schedule I substances. See ACT, 930 F.2d at 940.
The Administrator's interpretation of that criterion
meets our objection.
The Final Order discards the earlier formulation
and applies a new five-part test for determining
whether a drug is in "currently accepted medical
use":
(1) The drug's chemistry must be known
and reproducible;
(2) there must be adequate safety studies;
(3) there must be adequate and well-
controlled studies proving efficacy;
15 F.3d 1131 (D.C. Cir. 1994)
(4) the drug must be accepted by qualified
experts; and
(5) the scientific evidence must be widely
available.
57 Fed.Reg. at 10,506. None of these criteria is
impossible for a Schedule I drug to meet; in fact,
petitioners concede in their briefs that the new
standard has corrected the flaws we identified in
ACT.
B. Petitioners' Other Arguments
Petitioners make two additional arguments: (1)
They assert that they were deprived of the
opportunity to conform their evidentiary
submissions to the governing legal standard
because the previous Administrator had failed to
publish the eight-factor test on which he relied, as
required by the Freedom of Information Act
("FOIA"), 5 U.S.C. § 552(a)(1)(D), until two
weeks after the close of the evidence in the
rescheduling proceeding; and (2) they claim that
the Administrator's ruling was not the product of
reasoned decisionmaking because he was biased
and ignored the record.
While Alliance and NORML had apparently
raised these issues in ACT, we did not expressly
address them; nor did we decide them by
necessary implication because our limited remand
in ACT could have reflected a decision to postpone
consideration of these remaining arguments.
Accordingly, we conclude that ACT did not
establish the law of the case as to these issues. See
Bouchet v. Nat'l Urban League, 730 F.2d 799, 806
(D.C. Cir. 1984) ("[O]nly when an issue not
expressly addressed must have been decided by
`necessary implication' will the [law of the case]
doctrine be applied. . . .").
1. The FOIA Claim
Section 552(a)(1) of FOIA provides in relevant
1136 part: *1136
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 Alliance for Cannabis Therapeutics v. Drug Enforcement...
Each agency shall separately state and
currently publish in the Federal Register
for the guidance of the public —
.....
(D) . . . statements of general policy or
interpretations of general applicability
formulated and adopted by the agency. . . .
.....
Except to the extent that a person has
actual and timely notice of the terms
thereof, a person may not in any manner . .
. be adversely affected by a matter
required to be published in the Federal
Register and not so published.
5 U.S.C. § 552(a)(1) (emphasis added). This
provision requires agencies to set out in advance
the legal standards that will be applied so that
"actions can be guided, and strategies planned."
Northern Calif. Pwr. Agency v. Morton, 396
F.Supp. 1187, 1191 (D.D.C.), aff'd mem. sub. nom.
Northern Calif. Pwr. Agency v. Kleppe, 539 F.2d
243 (D.C. Cir. 1976). To establish a claim under
the statute, however, the litigant must show that
"he was adversely affected by a lack of publication
or that he would have been able to pursue an
alternative course of conduct" had the information
been published. Zaharakis v. Heckler, 744 F.2d
711, 714 (9th Cir. 1984).
Petitioners argue that the Administrator violated
the statute by using the eight-factor test to evaluate
the evidence presented in the marijuana
rescheduling petition. As the test was not
published until 17 days after the close of the
evidence, they contend that they were "adversely
affected" by the Administrator's reliance on the
test because they had no opportunity to tailor their
evidence to meet its requirements. Accordingly,
they ask us to remand the case to the
Administrator with instructions to reopen the
record for the submission of new evidence.
15 F.3d 1131 (D.C. Cir. 1994)
We decline to do so because petitioners have
failed to demonstrate that they have in fact been
adversely affected by the lack of notice. During
the nearly two years between the publication of
the eight-factor test on February 22, 1988, and the
Administrator's ruling on December 29, 1989,
petitioners never sought to reopen the record. As
parties to an important controversy, they had a
responsibility to proffer any evidence that was
made newly relevant by the adoption of the
criteria. Their failure to do so suggests either that
they were satisfied that the evidence already
presented would meet the test or that they had no
further evidence to offer. Thus, we have no reason
to believe that petitioners would have pursued an
"alternative course of conduct" had the test been
published earlier. Zaharakis, 744 F.2d at 714.
Furthermore, we do not agree that McLouth Steel
Products v. Thomas, 838 F.2d 1317 (D.C. Cir.
1988), supports their position. That case is
distinguishable. McLouth arose in the context of a
rulemaking in which an agency failed to identify
adequately a key standard in its notice of proposed
rulemaking in violation of 5 U.S.C. § 553. Unlike
petitioners, the McLouth challengers knew the
governing legal standard by the time they were
called on to submit evidence; their complaint was
that they had not had a chance to challenge the
standard at the time it was adopted. 838 F.2d at
1322-23. We held that the challengers were not
required to demonstrate that the failure of notice
had caused "specific prejudice" because "we
cannot say with certainty whether petitioners'
comments would have had some effect [on the
adoption of the standard] if they had been
considered when the issue was open." Id. at 1323-
24. Here, petitioners' challenge is not to the
standard but to their claimed inability to respond
to it.
2. The Reasoned Decisionmaking
Claim
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In ACT, Alliance and NORML argued that the
prior Administrator had been biased and ignored
the record. On this appeal, petitioners repeat these
claims and accuse his successor of the same
errors. We need not consider whether the previous
Administrator's ruling stemmed from reasoned
decisionmaking, however, because we remanded it
to the agency. We thus confine our review to the
current Administrator's treatment of the record in
the Final Order.
In support of their bias claim, petitioners point to
what they describe as a long history of the Drug
1137 Enforcement Administration's *1137 anti-
marijuana prejudice as evidenced by this court's
need to remand their petition on four occasions
and what they describe as the prior Administrator's
"unusually strident decision" rejecting the
administrative law judge's recommendation that
the drug be rescheduled. They also cite various
statements by the present Administrator in the
Final Order as evidence of a lack of objectivity.
See, e.g., 57 Fed.Reg. at 10,502 ("The only
favorable evidence that could be found by
[petitioners] consists of stories by marijuana
users"); id. ("[s]ick people are not objective
scientific observers, especially when it comes to
their own health."); id. at 10,503 ("Sick men,
women and children can be fooled by these claims
and experiment with the drug. . . . It is a cruel
hoax to offer false hope to desperately ill
people.").
We are not impressed. The need to remand a case
several times is not evidence per se of agency
prejudice. Nor do we think the statements cited by
petitioners show that the Administrator was unfair,
especially when considered in the context of a
reasonable preference for rigorous scientific proof
over anecdotal evidence, even when reported by
respected physicians.
15 F.3d 1131 (D.C. Cir. 1994)
Moreover, our review of the record convinces us
that the Administrator's findings are supported by
substantial evidence. See 21 U.S.C. § 877 (1988)
(substantial evidence standard applies to findings
of fact in rescheduling proceedings). The Final
Order canvasses the record at length. It recites the
testimony of numerous experts that marijuana's
medicinal value has never been proven in sound
scientific studies. The Administrator reasonably
accorded more weight to the opinions of these
experts than to the anecdotal testimony of laymen
and doctors on which petitioners relied. The
Administrator noted that
[w]ith one exception, none of [these
doctors] could identify under oath the
scientific studies they swore they relied on.
Only one had enough knowledge to
discuss the scientific technicalities
involved. Eventually, each one admitted he
was basing his opinion on anecdotal
evidence, on stories he heard from
patients, and on his impressions about the
drug.
Final Order, 57 Fed.Reg. at 10,502-03. These
findings are consistent with the view that only
rigorous scientific proof can satisfy the CSA's
"currently accepted medical use" requirement. Id.
at 10,500.
III. CONCLUSION
For the foregoing reasons, the petitions for review
are
Denied.